Disclosure: I am short CLSN. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.
In my first article, Celsion's HEAT Study: A Far From Certain Outcome, I delineated why one should be cautious in interpreting Celsion's (CLSN) ThermoDox Phase I trial as a proxy for a potential Phase III success. Even the most bullish of investors would ultimately concede that extrapolating from small datasets to larger trials presents a challenge. Nonetheless, despite the absence of robust ThermoDox data, arguments have continued to highlight literature that supports a potential role for doxorubicin efficacy in the treatment of unresectable hepatocellular carcinoma (HCC) in patients with greater than 3 cm tumors. Those include the use of chemotherapy as part of Transcatheter Arterial Chemoembolization (TACE) procedures as well as doxorubicin-eluting bead (DEB) embolization. More recently, a published meta-analysis suggesting a survival benefit for radiofrequency ablation (RFA) plus TACE over RFA alone has been highlighted as evidence of potential ThermoDox Phase III trial success.

In this article, I will highlight arguments that demonstrate a marginal role, if any, for doxorubicin in the treatment of HCC. Further, I will refute the parallels between TACE, DEB-TACE and ThermoDox, adding to the body of evidence that the HEAT trial will most likely fail. READ FULL ARTICLE HERE